Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 068...
FDA Device Recall #Z-2832-2020 — Class II — July 27, 2020
Recall Summary
| Recall Number | Z-2832-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 27, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Datascope Corporation |
| Location | Fairfield, NJ |
| Product Type | Devices |
| Quantity | 16104 WW |
Product Description
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Reason for Recall
Potential Endotoxin Contamination
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
Lot / Code Information
Kit Lot Number: 3000047433 3000048714 3000049793 3000053296 3000054596 3000055303 3000056631 3000060227 3000064257 3000070321 3000071835 3000072581 3000072582 3000076925 3000078405 3000079518 3000080107 3000083511 3000084721 3000087689 3000092131 3000092215 3000095792 3000096364 3000097534 3000100872 3000102116 3000106750 3000107623 3000112279 3000047432 3000047933 3000049794 3000052255 3000055306 3000056632 3000061197 3000064258 3000065635 3000066086 3000066265 3000067264 3000067841 3000068601 3000068602 3000074729 3000074850 3000079519 3000081079 3000080541 3000083512 3000084722 3000087474 3000087973 3000089282 3000092129 3000092130 3000095793 3000097645 3000096762 3000097644 3000097643 3000103157 3000104738 3000106751 3000107624 3000112280 3000047434 3000047523 3000048024 3000048025 3000049795 3000052254 3000053295 3000054426 3000054425 3000055305 3000059063 3000060228 3000061341 3000064844 3000072583 3000081622 3000082248 3000082188 3000083990 3000084723 3000099218 3000104736 3000104737 3000106752 3000047309 3000047934 3000049796 3000066797 3000074731 3000083513 3000079520 3000083514 3000095794 3000096366 3000102115 3000106753 3000112278 3000047355 3000048228 3000050257 3000052253 3000054424 3000055304 3000056630 3000059062 3000060229 3000061195 3000061196 3000064259 3000064355 3000066796 3000069443 3000070319 3000080729 3000077201 3000078053 3000078919 3000080419 3000083599 3000084691 3000085499 3000086793 3000086794 3000089346 3000091874 3000090851 3000091873 3000093117 3000093118 3000093119 3000094614 3000094613 3000095319 3000095854 3000096761 3000097533 3000099217 3000100871 3000102117 3000103158 3000104739 3000106898 3000107622 3000112281 3000114254 3000071786 3000073203 3000096365 3000103156
Other Recalls from Datascope Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0131-2023 | Class II | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), ... | Aug 5, 2022 |
| Z-1687-2022 | Class II | Insertion Kit for use with SENSATION PLUS 8F. 5... | Aug 5, 2022 |
| Z-1686-2022 | Class II | Sensation Plus 8Fr 50cc Intra-Aortic Balloon Ca... | Aug 5, 2022 |
| Z-1685-2022 | Class II | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter | Aug 5, 2022 |
| Z-2839-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-... | Jul 27, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.